Phase 2 trial of pegylated liposomal doxorubicin in advanced endometrial cancer

J Cancer Res Clin Oncol. 2003 Nov;129(11):651-4. doi: 10.1007/s00432-003-0497-8. Epub 2003 Sep 23.

Abstract

Purpose: To evaluate the efficacy and toxicity of pegylated liposomal doxorubicin in patients with advanced endometrial cancer.

Methods: Pegylated liposomal doxorubicin was administered at a dose of 40 mg/m2, and repeated on an every 28-day schedule.

Results: A total of 19 patients were enrolled in this phase 2 trial. Fourteen patients had received prior chemotherapy (carboplatin/paclitaxel-9; cisplatin/paclitaxel-3; single agent paclitaxel-2), seven prior radiation therapy, and three prior hormonal therapy. No patients had previously received doxorubicin. Two patients (11%) developed grade 1 hand-foot syndrome following treatment with pegylated liposomal doxorubicin. There were no episodes of cardiac dysfunction (>10% reduction in baseline ejection fraction). Three patients required hospitalization for nausea, vomiting, anemia, and dehydration. Only 2 (11%) patients required dose reduction. Four of 19 patients (21%; 95% CI: 3-39%) evaluable for response exhibited objective and subjective evidence of an antineoplastic effect of therapy (duration of responses: 2 months, 3 months, 4 months, 6+ months).

Conclusion: The pegylated liposomal doxorubicin regimen employed in this trial exhibited an acceptable toxicity profile (cardiac dysfunction, hand-foot syndrome). Definite, although modest, antineoplastic activity in a patient population with recurrent or advanced endometrial cancer was documented.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Antibiotics, Antineoplastic / therapeutic use*
  • CA-125 Antigen / metabolism
  • Doxorubicin / adverse effects
  • Doxorubicin / therapeutic use*
  • Drug Evaluation
  • Endometrial Neoplasms / drug therapy*
  • Female
  • Humans
  • Liposomes
  • Middle Aged
  • Polyethylene Glycols

Substances

  • Antibiotics, Antineoplastic
  • CA-125 Antigen
  • Liposomes
  • Polyethylene Glycols
  • Doxorubicin